Recall Z-0609-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
| Date | Dec 21, 2023 (initiated Oct 26, 2023) |
| Status | Open, Classified |
| Reason | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthineers issued Urgent Medical Device Correction POC 24-004.A.US on November 1, 2023 to US customers. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. If you experience this issue, you may request a no-charge replacement or receive a credit from your local Siemens Healthineers representative. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please re |
| Quantity | 3505 Cartridges US |
| Distribution | Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Cambodia Canada Chile China Colombia Congo, Republic Costa Rica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS Siemens Healthcare Diagnostics, Inc., Oct 12, 2012 |